Official Title

A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker

Summary:

Studies have shown that the study drug, pembrolizumab, works by helping the immune system. In
this way, pembrolizumab may help to slow the growth of melanoma or may cause cancer cells to
die. Compared to standard treatments, pembrolizumab seems to lengthen the time patients lived
overall and the time without their cancer getting worse.

Trial Description

Primary Outcome:

Measurement of tumour texture by CT scan

Secondary Outcome:

Measure tumour texture by CT for correlation with time to disease progression

Duration of response rate assessed by CT scan

Overall survival

Compare cost per quality adjusted life years between pembrolizumab and dacarbazine by collecting information from patients on health care resources used

Compare cost per quality adjusted life years between pembrolizumab and ipilimumab by collecting information from patients on health care resources used

Number and severity of adverse events using CTCAE v4

Overall response rate assessed by CT scan

The main purpose of this study is to find out if a type of CT (computed topography) scan can
help to know if pembrolizumab is working. This CT scan (called Texture Analysis) looks at the
tumour in fine detail. The use of this type of CT scan has not been studied in patients with
metastatic melanoma. Investigators want to see if this CT scan will show if some patients
being treated with pembrolizumab respond better than others.
One of the other purposes is to compare the costs within this trial to costs of the standard
of care.